Thema: Presse: Fast Track Designation from FDA for anti-cancer therapy
Presse: Fast Track Designation from FDA for anti-cancer therapy
Tom[a]
27.08.2003 23:35:58
TransMolecular, Inc. Receives FDA Fast Track Designation For 131-I-TM-601, Its Lead Compound For Brain Cancer
TransMolecular, Inc. today announced that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational anti-cancer therapy, 131-I-TM-601, for the treatment of malignant glioma, a deadly form of brain cancer.
Under the FDA Modernization Act of 1997, designation as a ´Fast Track´ drug means that the FDA will facilitate and expedite the development and review of the applications for the approval of a new drug, if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need.
"The Fast Track Designation from the FDA for 131-I-TM-601 is another milestone in a line of significant achievements for our company," said Matthew A. Gonda, Ph.D., president and CEO of TransMolecular. "We see the Fast Track Designation as a further method of expediting the development of our lead compound used to treat patients with one of the most serious forms of brain cancer. The robustness and versatility of this compound provides a platform for developing exciting new treatments for a variety of cancers, strengthening our oncology pipeline."
131-I-TM-601 is comprised of TM-601, a synthetic form of a peptide derived from the venom of a giant yellow Israeli scorpion, conjugated to 131-I, a medicinal form of iodine. TM-601 specifically seeks out and binds to its target -- a receptor selectively expressed on tumor cells, but not found on the surface of normal cells. When TM-601 is chemically linked to known anti-cancer agents, the combination of the two creates a powerful anti-cancer drug, which very effectively deliver their therapeutic payload only to targeted tumor cells.
TransMolecular recently completed patient enrollment in its first Phase I/II clinical trial of 131-I-TM-601 for the treatment recurrent glioma. A Phase II multi-center study of 131-I-TM-601 for the treatment of recurrent glioma is anticipated to begin later this year. The FDA has granted 131-I-TM-601 Orphan Drug Designation for use in glioma.
TransMolecular, Inc. today announced that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational anti-cancer therapy, 131-I-TM-601, for the treatment of malignant glioma, a deadly form of brain cancer.
Under the FDA Modernization Act of 1997, designation as a ´Fast Track´ drug means that the FDA will facilitate and expedite the development and review of the applications for the approval of a new drug, if it is intended for the treatment of a serious or life-threatening condition and demonstrates the potential to address an unmet medical need.
"The Fast Track Designation from the FDA for 131-I-TM-601 is another milestone in a line of significant achievements for our company," said Matthew A. Gonda, Ph.D., president and CEO of TransMolecular. "We see the Fast Track Designation as a further method of expediting the development of our lead compound used to treat patients with one of the most serious forms of brain cancer. The robustness and versatility of this compound provides a platform for developing exciting new treatments for a variety of cancers, strengthening our oncology pipeline."
131-I-TM-601 is comprised of TM-601, a synthetic form of a peptide derived from the venom of a giant yellow Israeli scorpion, conjugated to 131-I, a medicinal form of iodine. TM-601 specifically seeks out and binds to its target -- a receptor selectively expressed on tumor cells, but not found on the surface of normal cells. When TM-601 is chemically linked to known anti-cancer agents, the combination of the two creates a powerful anti-cancer drug, which very effectively deliver their therapeutic payload only to targeted tumor cells.
TransMolecular recently completed patient enrollment in its first Phase I/II clinical trial of 131-I-TM-601 for the treatment recurrent glioma. A Phase II multi-center study of 131-I-TM-601 for the treatment of recurrent glioma is anticipated to begin later this year. The FDA has granted 131-I-TM-601 Orphan Drug Designation for use in glioma.
Tom[a]
